Regulatory News

Environmental toxicology
specialists at the Federal Institute of Aquatic Science and Technology (Eawag)
have received international certification for a non-animal test used to
determine acute toxicity of water samples and chemicals to fish. According to
Eawag this is the first time a toxicity test with cultured gill cell lines from
fish has been ISO-certified. There still is a lack of recognised alternatives
to experiments with live fish. In 2017, researchers in Switzerland carried out
more than 7,500 ecotoxicological tests with the aim of protecting humans,
animals and the environment. Eawag has been researching alternatives to reduce
or replace fish experiments. One of these alternatives involves experiments
with a gill cell line of rainbow trout (RTgill W1 cell line). The test saves
time, is cost-effective and does not require any laboratory animals. More info:https://www.eawag.ch/en/news-agenda/news-portal/news-detail/news/statt-tierversuche-fischzellentest-international-zertifiziert/

The Science, Education and
Culture Committee (SECC) recommends the Swiss National Council reject a
parliamentary initiative requesting to ban the most severe constraints in
animal experimentations. The initiative, submitted by Maya Graf of the Green
Party, aims to ban animal experiments classified as severity 3, which cause
medium to long-term moderate pain, suffering, injury or severe fear or health
impairment. The National Council will discuss the initiative in the autumn.
More info: https://www.parlament.ch/press-releases/Pages/mm-wbk-n-2019-05-24.aspx?lang=1031

The Federal Food Safety and Veterinary Office will host the 3R Symposium on Alternatives to Carbon Dioxide on 5 June 2019 at the Campus Liebefeld in Bern. After an introduction on the challenges, speakers will present a systematic review of carbon dioxide in mice and rats as well as the revised euthanasia guideline published by the American Veterinary Medical Association. The organisers then plan to present a first draft of a research strategy to replace the use of carbon dioxide with alternatives for all animal species and all purposes, and participants will be able to comment. More information will follow over the coming weeks. More info: https://swiss3rcc.org/wp-content/uploads/2019/02/3R_Symposium_-_Alternatives_to_CO2_-_June-5-2019-Programme.pdf

Different audiences can better understand scientific uncertainties when expressions and communications formats are tailored to their needs. The European Food and Safety Authority’s new and targeted approach to uncertainty communication will help communicators to further boost the transparency of its scientific advice. The communication approach aims to increase understanding of how scientific experts express their confidence in the methods and underlying scientific evidence used in their assessments, and in their conclusions about potential risks. More info: www.efsa.europa.eu/en/press/news/190116

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents. The ECBS bases its recommendations on the consideration that the omission of the abnormal toxicity test would not compromise the quality and safety of vaccines and other biological products. Animal tests such as the abnormal toxicity test were developed for the safety testing of human vaccines at a time when limited scientific knowledge for the quality control of biological products existed. Over the past decades, researchers have identified viable alternatives, and current manufacturing processes, including the Good Manufacturing Practices (GMP) and in-process quality controls, can ensure a more appropriate level of quality and safety for vaccines and other biological products than the abnormal toxicity test. More info: www.edqm.eu/sites/default/files/press_release_edqm_welcomes_recommendation_on_innocuity_test_november_2018.pdf

The updated notes of guidance from the Scientific Committee on Consumer
Safety (SCC) has published. In this 10th revision, the
state-of-the-art with respect to the validated methods of the 3Rs (Refinement,
Reduction and Replacement) strategy of Russell et al. (1959), is incorporated
with emphasis on New Approach Methodologies (NAMs). In view of the testing and
marketing bans in the cosmetic regulation, the SCCS gives special attention to
those alternative methods that are suitable for the safety testing of cosmetic
substances. More info: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_224.pdf

The Organisation for Economic Cooperation and Development (OECD) has published a new Guidance Document (n. 286) on Good In Vitro Method Practices to promote the reliability and integrity of in vitro data used for the safety assessment of chemicals. The document aims at providing technical guidance in order to advance the development of robust and reliable in vitro methods suitable for regulatory purposes. The guidance is targeted primarily at users that implement in vitro methods, but also provides guidance for in vitro method developers. The document contains among others: – Detailed updated information on good practices for in vitro methods; – Description of the key aspects that may impact the reliability and relevance of in vitro data; – Guidance to help ensure that Standard Operating Procedures (SOPs) are well designed, robust, well defined and described. – Description of the importance of reporting criteria, applying good experimental design, establishing acceptance criteria, and performance standards based on scientific evidence from the generated in vitro datasets. More info.

The Federal Food Safety and Veterinary Office (FSVO) and the cantonal and national veterinary services are jointly responsible for an efficient animal welfare in line with the Swiss Animal Protection Act. The Swiss animal protection report 2018, which the FSVO just published in 3 / 4 German, French and Italian, gives an overview of the recently completed and still running projects, including a section about the Swiss 3RCC. More info.

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published the Memorandum on weight of evidence and uncertainties. The Memorandum explains how the SCHEER applies the weight of evidence 2 / 5 approach (WoE) and how it deals with analysis and description of uncertainties when conducting risk assessments of stressors to which humans and/or the environment might be exposed. More info.